Z-0769-2019 Class I Terminated
FDA device recall Z-0769-2019 was initiated by WEST PHARMA. SERVICES IL, LTD on December 26, 2018 and is designated Class I. Reason for recall: Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC. The recall status is terminated (terminated July 20, 2022). Affected quantity: 30 million units.
Recall Details
- Product Type
- Devices
- Report Date
- February 6, 2019
- Initiation Date
- December 26, 2018
- Termination Date
- July 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 million units
Product Description
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Reason for Recall
Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC.
Distribution Pattern
US Distributor in MO
Code Information
UDI: (01)07290108240054(17)190101(10)7689(90)36098126(91)6070112 Lot Numbers: 7689, 7690, 7750, 7751, 7865, 7866, 7867, 7868, 7886, 7887, 7888, 7900, 7901, 7902, 7957, 7958, 7959, 7960, 7949, 7951, 7952, 7954, 8019, 8020, 8021, 8022, 8132, 8133, 8134, 8135, 8136, 8137, 8138, 8139, 8140, 8141, 8142, 8143, 8144, 8145, 8147, 8148, 8149, 8150, 8151, 8470, 8471, 8472, 8473, 8483, 8696, 8553, 8554, 8555, 8556, 8557, 8558, 8559, 8560, 8561, 8562, 8563, 8564, 8565, 8566, 8567, 8568, 8569, 8570, 8571, 8760, 8761, 8762, 8763, 8764, 8765, 8766, 8767, 8768, 8769, 8770, 8771, 8772, 8887, 8888, 8889, 8890, 8891, 8892, 8893, 8894, 8895, 9040, 9041, 9042, 9042, 9043, 9044, 9045, 9046, 9047, 9169, 9170, 9171, 9172, 9173, 9174, 9271, 9272, 9273, 9274, 9275, 9276, 9277, 9278, 9323, 9324, 9325, 9326, 9327, 9328, 9329, 9330, 9394, 9500, 9501, 9502, 9503, 9504, 9505, 9506, 9507, 9508, 9509, 9510, 9511, 9512, 9513, 9514, 9515, 9529, 9530, 9531, 9532, 9533, 9534, 9535, 9537, 9560, 9561, 9562, 9563, 9564, 9565, 9566, 9567, 9568, 9569, 9570, 9571, 9572, 9657, 9658, 9659, 9660, 9661, 9662, 9663, 9664, 9665, 9666, 9667, 9668, 9717, 9718, 9719, 9720, 9721, 9722, 9723, 9724, 9725, 9726, 9727, 9728, 9729, 9730, 9810, 9841, 9842, 9843, 9844, 9845, 9846, 9847, 9848, 9849, 9964, 9965, 9966, 9967, 9968, 9969, 9970, 9971, 9972, 9973, 9974, 9975, 9976, 9978, 9979, 9980, A018, A019, A001, A002, A003, A004, A005, A020, A021, A022, A023, A024, A025, A026, A027, A028, A029, A030, A031, A032, A033, A034, A006, A007, A008, A009, A010, A011, A012, A013, A014, A015, A016, A017, A106, A107, A108, A109, A110, A111, A258, A112, A113, A114, A115, A116, A117, A118, A119, A120, A121, A122, A254, A321, A322, A323, A330, A343, A344, A345, A346, A347, A348, A349, A350, A351, A352, A353, A354, A355, A324, A325, A326, A327, A328, A329, A331, A332, A333, A334, A335, A336, A337, A356, A357, A358, A359, A360, A361, A362, A338, A339, A340, A519, A520, A521, A522, A523, A524, A525, A526, A527, A528, A529, A530, A530, A531, A532, A533, A534, A535, A536, A537, A538, A539, A540, A541, A542, A543, A544, A545, A546, A547, A548, A549, A550, A551, A552, A553, A554, A555, A556, A557, A558, A559, A560, A561, A562, A563, A564, A565, A566, A568, A569, A570, A571, A572, A567, A573, A574, A575, A576, A577, A578, A579, A580, A581, A582, A817, A819, A813, A814, A815, A816, A818, A820, A821, A822, A823, A824, A825, A826, A840, A840, A841, A842, A843, A843, A845, A844, A898, A899, A900, A901, A902, A903, A904, A905, A906, A907, A908, A909, A910, A911, A915, A916, A917, A918, A919, A920, A921, A982, A983, A984, A985, A986, A987, A988, C015, C016, C017, C017, C033, C034, C035, C036, C037, C038, C039, C040, C041, C042, C043, C044, C045, C046, C047, C048, C049, C050, C051, C052, C053, C054, C055 & C056 UDI: (01)07290108241006(17)190501(10)8344(90)36098138(91)6070112C Lot Number: 8344